Amerathon Health Llc Dba American Health

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to calibrate one of one Hematology analyzer (DXH-900, serial # BD38532), for twelve of twelve months (January through December) 2021 and four of four patient test reports (Pt#1-Pt#4) reviewed. Findings include: 1) Review of policy titled, "Beckman Coulter Unicel DxH Series Calibration Procedure, Policy Number 9-111-3M", laboratory director approval date 3-5-2020, read "C. Calibration Frequency... 2. The laboratory must calibrate and/or verify calibration at least every six months and on an 'as needed' basis to ensure accuracy of the system..." (page 3 of 7, section C). 2) Review of calibration data for Hematology testing indicated none was available for review in 2021. 3) Medical record review indicated the following four patients had Hematology testing performed in 2021: Pt# Result Date Pt#1 WBC=6.3 K/cmm 1/26/21 Pt#2 RBC=4.09 M/cmm 4/23/21 Pt#3 Hgb=9.9 g/dL 6/23/21 Pt#4 Hct=34.7 % 11/17/21 Pt#=patient number WBC=White Blood Cell K/cmm=cells per microliter RBC=Red blood Cell M /cmm=cells per microliter Hgb = Hemoglobin g/dL=grams per deciliter Hct=Hematocrit 4) In interview on 9/26/22 at 1:02 pm, SP-2 (Testing Personnel) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- confirmed no calibrations were performed in 2021 on the DXH-900 series analyzer used for Hematology testing. 5) Approximate annual test volume for Hematology=12, 254,368. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibration verification/linearities on two of two analyzers (Hematology: DXH-900/Serial# BD38532 and Chemistry: Au-5800/Serial# 2018013706) for twelve of twelve months (January through December) 2021 and eight of eight patients (Pt#1-Pt#8) reviewed. Findings include: 1) Review of policy titled, "Beckman Coulter Unicel DxH Series Calibration Procedure, Policy Number 9-111-3M, laboratory director approval date 3- 5-2020, read "C. Calibration Frequency... 2. The laboratory must calibrate and/or verify calibration at least every six months and on an 'as needed' basis to ensure accuracy of the system..." (page 3 of 7, section C). 2) Review of policy titled, "Chemistry Calibration, Calibration Verification and AMR Guidelines, Policy Number 8-101.3M," (AMR = Analytic Measurement Range) laboratory director approval date 12-5-2019, read "D. Calibration Verification Frequency. 1) Same as for AMR Verification frequency listed below... 3. Calibration and AMR Verification Frequency... 6. At least every six months..." (page 3 and 4, section D). 3) Review of calibration, calibration verification and AMR data for Hematology and Chemistry testing indicated none was available for review from 2021. 4) Medical Record review indicated the following patients had Hematology and Chemistry testing performed in 2021: a. Hematology: Pt# Result Date Pt#1 WBC=6.3 K/cmm 1/26/21 Pt#2 RBC=4. 09 M/cmm 4/23/21 Pt#3 Hgb=9.9 g/dL 6/23/21 Pt#4 Hct=34.7 % 11/17/21 b. Chemistry: Pt# Result Date Pt#5 Sodium=134 mEq/L 1/29/21 Pt#6 Potassium=4.7 mEq/L 6/21/21 Pt#7 Calcium=8.4 mg/dL 10/20/21 Pt#8 Chloride=109 mEq/L 11/17 /21 Pt#=patient number WBC=White Blood Cell K/cmm=cells per microliter RBC=Red blood Cell M/cmm=cells per microliter Hgb=Hemoglobin g/dL=grams per deciliter Hct=Hematocrit mEq/L=millimeter equivalents per liter mg/dL=milligram -- 2 of 3 -- per deciliter 5) Upon request for calibration verification documentation, on 9/26/22 at 1:35 pm, SP-2 confirmed no calibration verification/linearities and/or AMR verification was performed the Hematology and Chemistry analyzers in 2021. 6) Total approximate annual test volume for Hematology and Chemistry=28,539,745. -- 3 of 3 --

Summary Statement of Deficiencies D5779

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on document review and interview, the laboratory failed to successfully participate in the College of American Pathologists (CAP) proficiency testing (PT) program for lactate dehydrogenase (LDH). The laboratory had two consecutive unsatifactory testing events (Events 1 and 2, 2020). (Refer to D2096.) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to achieve a proficiency testing (PT) score of 80% or higher for lactate dehydrogenase (LDH) testing during two consecutive PT events (Event 1, 2020 and Event 2, 2020), resulting in unsatisfactory performance. Findings included: 1. Review of "CASPER Report 0155D" indicated the laboratory received a score of 0% during PT testing events 1 and 2, 2020 for LDH testing. 2. In interview on 7-28-2020 at 3:15 PM, SP1, Laboratory Manager, acknowledged the laboratory received a score of 0% during PT events 1, 2020 and 2, 2020 for LDH testing. -- 2 of 2 --